EP4311560A1 - Procédé d'introduction des articles provenant d'un récipient dans la chambre de traitement d'une enceinte de confinement dans des conditions aseptiques et dispositif d'introduction correspondant - Google Patents

Procédé d'introduction des articles provenant d'un récipient dans la chambre de traitement d'une enceinte de confinement dans des conditions aseptiques et dispositif d'introduction correspondant Download PDF

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Publication number
EP4311560A1
EP4311560A1 EP22187101.5A EP22187101A EP4311560A1 EP 4311560 A1 EP4311560 A1 EP 4311560A1 EP 22187101 A EP22187101 A EP 22187101A EP 4311560 A1 EP4311560 A1 EP 4311560A1
Authority
EP
European Patent Office
Prior art keywords
container
process chamber
cover
passage
articles
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22187101.5A
Other languages
German (de)
English (en)
Inventor
Julia Annette CARLI
Philipp LEUENBERGER
Mathieu MÜLLER
Christophe RETHORET
Tobias Jan SCHNEIDLER
Marc TONDERA
Mike Zeller
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SKAN AG
Original Assignee
SKAN AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by SKAN AG filed Critical SKAN AG
Priority to EP22187101.5A priority Critical patent/EP4311560A1/fr
Priority to PCT/CH2023/000003 priority patent/WO2024020705A1/fr
Publication of EP4311560A1 publication Critical patent/EP4311560A1/fr
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • A61L2/10—Ultraviolet radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/20—Gaseous substances, e.g. vapours
    • A61L2/208—Hydrogen peroxide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/24—Apparatus using programmed or automatic operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20—Targets to be treated
    • A61L2202/23—Containers, e.g. vials, bottles, syringes, mail

Definitions

  • the present invention relates to a method and a lock arrangement positioned in an installation room for introducing articles under aseptic conditions from serially supplied containers into a process chamber of a containment surrounded by a housing.
  • a single container includes a container with an aseptic interior and a passage closed with a cover.
  • the items stored inside should be treated in the process chamber after the cover is opened.
  • the containers of the containers have the shape of trough-shaped tubs, and the items are, for example, pharmaceutical vials, vials or syringes that are placed in systematically arranged trough-shaped receiving contours of nests.
  • WO 2020/016 645 A2 is an arrangement for the contamination-free introduction of a sterile object from a container, which is closed with a semi-permeable cover, into a working chamber of a containment surrounded by a wall.
  • the arrangement initially comprises a gate unit with an access flange arranged in the wall, which forms a passage from the outside into the working chamber, and a door that tightly closes the passage and can be moved to the open position in the working chamber.
  • the arrangement also includes a container holder with a catcher for holding a container placed in the container holder, an opening for introducing the container into the catcher and a flange for interacting with the access flange.
  • a decontamination unit is intended to cover an outer surface of the cover facing the door when the door is closed, the container holder is docked to the access flange and the container is stored in the container holder decontaminate.
  • the door In the closed position, the door is attached to the access flange in a sealed manner from the working chamber, and the access flange surrounds an intermediate space which lies in the passage.
  • the cover of the container placed in the container holder is sealed between the flange and the access flange when the container holder is pivoted towards the access flange.
  • the decontamination unit is installed directly on the door or on the side of the gate unit, which has the door and the access flange, with the direction of action into the passage.
  • the decontamination unit is designed as a radiation source, for example UVC, UV, e-beam or pulsed light, or as a gassing device, for example for nebulizing an H 2 O 2 solution.
  • the invention is based on the object of a more efficient method for the local area of application for introducing articles from a container into the process chamber of a containment under aseptic conditions and a lock arrangement suitable for this purpose to suggest.
  • the key factors here are the highest possible degree of automation, the extensive avoidance of manual intervention and the guarantee of high cleanliness requirements.
  • the method according to the invention or the lock arrangement according to the invention is designed for introducing articles under aseptic conditions from serially supplied containers into a process chamber of a containment surrounded by a housing by means of a lock arrangement positioned in an installation room. There is an entrance station in front of the process chamber.
  • a single container includes a container with an aseptic interior and a passage closed with a cover, with the items stored in the interior in the process chamber after the cover is opened are to be treated.
  • the decontamination device is integrated in the lid or arranged outside the lid, with the emission element of the decontamination device sitting directly in the lid or outside the lid in a receptacle.
  • a cutting tool is part of the tools used to cut open the cover.
  • at least parts of the cover and the covering consist of a semi-permeable nonwoven fabric, such as Tyvek® .
  • the cover keeps the interior of the container in a sterile state before removal and is sealed on an edge surrounding the passage of the container, for example by gluing or welding.
  • a removable nest is stored in the container to accommodate a large number of items, which is transferred to the process chamber together with the items. After the nest has been emptied of the articles in the process chamber, this emptied nest is disposed of from the process chamber into a next or the same emptied container pressed against the passage in question. Alternatively, the items are transferred directly from the nest remaining in the container to the process chamber.
  • the decontamination device is preferably used as a radiation source, for example UVC, UV, e-beam or pulsed light, or alternatively as a gassing device. e.g. for nebulizing an H 2 O 2 solution.
  • the container in the initially closed wrapper is positioned on a support.
  • a feed means is used to push the container out of the open casing with a displacement flow flowing onto the container.
  • the covering is held by a gripper, preferably designed as a suction cup.
  • the containers introduced into the input station are fed to the passages by means of at least one conveyor device and removed again via this conveyor device after processing.
  • the at least one conveyor device is preferably based on the principle of magnetic levitation technology and allows conveyance on several tracks, even in opposite directions.
  • the containers are transported within the entrance station by means of a first conveyor device, while a second conveyor device causes the containers to be swiveled in with the cover pressed onto the respective passage.
  • the second conveyor device is also used to remove processed containers can be used for the respective passage.
  • the second conveyor device preferably comprises a gimbal bearing.
  • Two gimbal bearings lying next to each other are each formed from a U-shaped carrier, which is connected in the third axis of rotation to a fork that is suspended in the second axis of rotation.
  • each passage which, together with the cover of a temporarily pressed container and/or a temporarily pressed lid, creates seals in the passages in the transition from the input station to the process chamber.
  • a seal instead of a conventional seal, you can provide a minimal gap or use a labyrinth seal.
  • the lid is supported by a pivoting arm of an apparatus positioned in the process chamber.
  • the at least one manipulator or the additional manipulator are preferably designed as robots.
  • the containers have the shape of trough-shaped tubs.
  • the items are, for example, vials, vials or syringes that are placed in systematically arranged receiving contours of nests.
  • the container 94 is, for example, a trough-shaped tub.
  • Articles 960 are in particular vials, vials or syringes.
  • At least parts of the cover 98 and the covering 99 preferably consist of a semi-permeable nonwoven fabric, such as Tyvek® .
  • the cover 98 is typically sealed on the edge 941 surrounding the passage 95 of the container 94 and thus keeps the interior 940 of the container 94 in a sterile state.
  • the front first zone 31 and the rear second zone 32 of the entrance station 3 are each equipped with a second conveyor device 35 .
  • a conveyor device 35 consists of an axis 350 and two gimbal bearings 351 fixed thereto.
  • a first axis of rotation D1 extends through the axis 350 .
  • Two forks 352 fixed side by side on the axis 350 can each be pivoted about a second axis of rotation D2 , which extend at right angles to the first axis of rotation D1 .
  • a support 353 which can be pivoted about a third axis of rotation D3 is suspended, with the first axis of rotation D1 and the third axis of rotation D3 running parallel to one another.
  • the carriers 353 are configured to grip under the edges 941 of the containers 94 when pivoting in and out of the passages 47, 48 leading from the input station 3 into the process chamber 43 .
  • the lock arrangement 1 installed in the installation room A is structured into an entrance station 3, a provision station 2 in front of it and that Containment 4 adjoining the entrance station 3 with its process chamber 43.
  • the preparation station 2 has the support 20 in order to position new, third containers 93 with the wrapping 99 initially still closed.
  • the feed means 22 is used to push out such third containers 93 from the opened casing 99 from the support 20 through the access 37 in the housing 39 surrounding the entrance station 3 onto the first conveyor 34 in the front first zone 31 of the entrance station 3.
  • the The gripper 21 present in the provision station 2 returns the casing 99 .
  • the second conveyor 35 adjoins the first conveyor 34 .
  • a supply air fan 360 and supply air filter 361 are arranged to generate a cleaned, downward laminar flowing air flow LF .
  • the partition 40 which has the first passage 47 between the zones 31, 41, extends between the front first zone 31 of the entrance station 3 and the front first zone 41 of the process chamber 43 .
  • the seal 470 is located in the first passage 47.
  • a supply air fan 460 and a supply air filter 461 are also located in the plenum 46 of the front first zone 41 of the containment 4 to generate a cleaned, downward laminar flowing air flow LF.
  • an exhaust air filter 431 is provided on the side and/or alternatively in its base and a waste opening 432 is provided in the base, which leads to a depot 433 .
  • an apparatus 5 with the boom 50 and the cover 51 held thereon, in which the decontamination device 7 is integrated, is stationed.
  • the cover 51 can be moved to the first passage 47 or the second passage 48 via intermediate positions.
  • the rear second zone 32 is located behind the first zone 31, and in the containment 4, the rear second zone 42 is located behind the first zone 41.
  • the second zone 32 is also equivalent to the first zone 31
  • Plenum 36 is equipped with a supply air fan 360 and a supply air filter 361 to generate an air flow LF .
  • the second zone 42 has the plenum 46 with supply air fan 460 and supply air filter 461 for generating the air flow LF.
  • a common supply air fan 360 and a common supply air filter 361 for the first zone 31 and the second zone 32 as well as a common supply air fan 460 and a common supply air filter 461 for the first zone 41 and the second zone 42 can be sufficient.
  • several supply air fans 360,460 or supply air filters 361,461 will be provided for zones 31,32 and 41,42 .
  • the exhaust air filter 431 and the waste opening 432 leading to a depot 433 are also present in the housing 49 on the side and/or alternatively in the bottom.
  • the partition 40 which now has the second passage 48 between the zones 32, 42, again extends between the rear second zone 32 of the input station 3 and the rear second zone 42 of the process chamber 43 .
  • the seal 480 sits in this second passage 48.
  • a manipulator 6 with the boom 60 and the tool head 61 located thereon is stationed in the process chamber 43 common to the first and second zones 41 , 42. By pivoting the boom 60 , the tool head 61 can be moved to the first passage 47 or the second passage 48 via intermediate positions.
  • the decontamination device 7 is not integrated in the cover 51 , as was previously the case, but the emission element of the decontamination device 7, for example a nebulization nozzle for introducing an H 2 O 2 aerosol, is not located in the cover 51, but outside in a holder 70.
  • This holder 70 can be formed in the simplest form by a fold of the partition 40 extending between the entrance station 3 containment 4 . The surface of the holder 70 facing the environment 8 is then part of the enclosed gas volume and environment 8 to be decontaminated in the production process.
  • the cover 51 is carried by a pivoting arm 50 of an apparatus 5 stationed in the process chamber 43 .

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Filling Of Jars Or Cans And Processes For Cleaning And Sealing Jars (AREA)
EP22187101.5A 2022-07-26 2022-07-26 Procédé d'introduction des articles provenant d'un récipient dans la chambre de traitement d'une enceinte de confinement dans des conditions aseptiques et dispositif d'introduction correspondant Pending EP4311560A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP22187101.5A EP4311560A1 (fr) 2022-07-26 2022-07-26 Procédé d'introduction des articles provenant d'un récipient dans la chambre de traitement d'une enceinte de confinement dans des conditions aseptiques et dispositif d'introduction correspondant
PCT/CH2023/000003 WO2024020705A1 (fr) 2022-07-26 2023-05-25 Procédé d'introduction d'articles depuis un récipient dans la chambre de traitement d'un dispositif de confinement dans des conditions aseptiques, et agencement de verrouillage associé

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP22187101.5A EP4311560A1 (fr) 2022-07-26 2022-07-26 Procédé d'introduction des articles provenant d'un récipient dans la chambre de traitement d'une enceinte de confinement dans des conditions aseptiques et dispositif d'introduction correspondant

Publications (1)

Publication Number Publication Date
EP4311560A1 true EP4311560A1 (fr) 2024-01-31

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP22187101.5A Pending EP4311560A1 (fr) 2022-07-26 2022-07-26 Procédé d'introduction des articles provenant d'un récipient dans la chambre de traitement d'une enceinte de confinement dans des conditions aseptiques et dispositif d'introduction correspondant

Country Status (2)

Country Link
EP (1) EP4311560A1 (fr)
WO (1) WO2024020705A1 (fr)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020016645A2 (fr) 2018-07-18 2020-01-23 Pharma Integration S.R.L. Dispositif pour l'infiltration sans contamination d'un objet stérile d'un contenant dans un confinement et procédé correspondant

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020016645A2 (fr) 2018-07-18 2020-01-23 Pharma Integration S.R.L. Dispositif pour l'infiltration sans contamination d'un objet stérile d'un contenant dans un confinement et procédé correspondant

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
BAESSLER H J ET AL: "Chapter 6 - Aseptic Transfer Systems Into and Out of Barrier Isolators and RABS", 1 January 2013 (2013-01-01), XP009512843, ISBN: 978-3-642-39291-7, Retrieved from the Internet <URL:https://www.springer.com/gp/book/9783642392917> *

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WO2024020705A1 (fr) 2024-02-01

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